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Performance Study of SONA Saliva C-19 Rapid Test

Primary Purpose

Covid19, Sars-CoV-2 Infection, Corona Virus Infection

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sona Saliva C-19 Rapid Test
Sponsored by
Sona Nanotech Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Covid19 focused on measuring Antigen, COVID19, Rapid Test, Saliva

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Up to 500 subjects will be screened, consented, and enrolled to obtain a minimum of 50 eligible candidates. In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Presenting to the Emergency Department at HRH.
  2. Receiving a COVID-19 RT-PCR test as per standard pathway of care.
  3. Provide written informed consent.

  4. Patients must be presenting or have experienced at least one (1) or more signs or symptoms of COVID-19 within ≤ 7 days:

    1. Fever as self-described or measured ≥ 38 °C (100.4°F)
    2. Chills
    3. Cough
    4. Shortness of breath
    5. Congestion or runny nose
    6. Difficulty Breathing
    7. Muscle or Body Aches
    8. Vomiting
    9. Diarrhea
    10. New loss of sense of taste or smell
    11. Headache
    12. General malaise
    13. Sore Throat

Exclusion Criteria:

  1. Asymptomatic patients.
  2. Patients unable to provide a saliva sample.
  3. Patients unable to give consent.
  4. Patients who will not be receiving a nasopharyngeal RT-PCR test.

Sites / Locations

  • Humber River Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SARS_CoV_2 Antigen Rapid Test

Arm Description

The same group of patients participated in two arms of the study: One arm was for obtaining performance data of the Sona Saliva C-19 Rapid test and the comparator arm was to obtain data from the primary care route using approved RT-PCR testing.

Outcomes

Primary Outcome Measures

Percent Positive Agreement and Negative Percent Agreement
Calculate the performance of the Sona Saliva C-19 Rapid Test when compared to RT- PCR using nasopharyngeal swab specimens.

Secondary Outcome Measures

Full Information

First Posted
May 3, 2021
Last Updated
March 22, 2023
Sponsor
Sona Nanotech Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04877002
Brief Title
Performance Study of SONA Saliva C-19 Rapid Test
Official Title
Novel Salivary Rapid Testing of SARS_CoV_2
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Limited participants
Study Start Date
April 29, 2021 (Actual)
Primary Completion Date
June 10, 2021 (Actual)
Study Completion Date
January 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sona Nanotech Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The Sona Saliva C-19 Rapid Test is a bioassay intended for rapid point-of-care detection of the SARS-CoV-2 virus. Performance of the Sona Saliva C-19 Rapid Test assay will be assessed by comparison to a RT-PCR reference method
Detailed Description
The clinical performance of the Sona Saliva C-19 Rapid Test will be evaluated in a prospective clinical study conducted at a single (1) investigational site in Toronto, Cananda. Consenting patients of ages 18+, any gender, or race/ethnicity who presents at the test site with COVID-19 like symptoms during the 2021 COVID-19 season will be asked to take part in the study, will be sequentially enrolled and tested. Trained operators with laboratory experience who have received training on the use of the Sona Saliva C-19 Rapid Test will conduct the testing and represent the intended users. A subject's participation in this study will consist of a single visit. Following the completion of the informed consent process, study questionnaire and a review of Inclusion/Exclusion criteria to determine eligibility, each subject will receive a unique study identification number, be asked to provide a sample for testing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Sars-CoV-2 Infection, Corona Virus Infection
Keywords
Antigen, COVID19, Rapid Test, Saliva

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The purpose of this study is to validate the performance of the Sona Saliva C-19 rapid Test for rapid detection of SARS_CoV_2 infection when using saliva specimens. A prospective randomized and blinded study to evaluate a rapid point of care antigen test for the detection of viral proteins and compared against an approved RT-PCR test. Saliva samples will be collected along with the current standard of care collection.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SARS_CoV_2 Antigen Rapid Test
Arm Type
Experimental
Arm Description
The same group of patients participated in two arms of the study: One arm was for obtaining performance data of the Sona Saliva C-19 Rapid test and the comparator arm was to obtain data from the primary care route using approved RT-PCR testing.
Intervention Type
Diagnostic Test
Intervention Name(s)
Sona Saliva C-19 Rapid Test
Intervention Description
Rapid Antigen diagnostic device performance comparative to RT-PCR
Primary Outcome Measure Information:
Title
Percent Positive Agreement and Negative Percent Agreement
Description
Calculate the performance of the Sona Saliva C-19 Rapid Test when compared to RT- PCR using nasopharyngeal swab specimens.
Time Frame
35 days from last patient enrolment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Up to 500 subjects will be screened, consented, and enrolled to obtain a minimum of 50 eligible candidates. In order to be eligible to participate in this study, an individual must meet all of the following criteria: Presenting to the Emergency Department at HRH. Receiving a COVID-19 RT-PCR test as per standard pathway of care. Provide written informed consent. Patients must be presenting or have experienced at least one (1) or more signs or symptoms of COVID-19 within ≤ 7 days: Fever as self-described or measured ≥ 38 °C (100.4°F) Chills Cough Shortness of breath Congestion or runny nose Difficulty Breathing Muscle or Body Aches Vomiting Diarrhea New loss of sense of taste or smell Headache General malaise Sore Throat Exclusion Criteria: Asymptomatic patients. Patients unable to provide a saliva sample. Patients unable to give consent. Patients who will not be receiving a nasopharyngeal RT-PCR test.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Jacobs, Dr
Organizational Affiliation
Humber River Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Humber River Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3M 0B2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Performance Study of SONA Saliva C-19 Rapid Test

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